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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K142153
Device Name HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
Applicant
Teleflexmedical, Inc.
2917 Weck Dr.
Durham,  NC  27709
Applicant Contact JAMES A COCHIE
Correspondent
Teleflexmedical, Inc.
2917 Weck Dr.
Durham,  NC  27709
Correspondent Contact JAMES A COCHIE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/06/2014
Decision Date 04/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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